Embracing Necessary Digital Transformation In Biomanufacturing

It is surprising that, given the abundant scientific and commercial innovation present in, our industry has been relatively slow to implement modern digital solutions in the manufacturing space. This is especially true in the realm of data analytics, where we continue to trail other industries.

For instance, many biopharmaceutical manufacturing processes still involve manual record-keeping, which presents a potential challenge to data integrity and limits the opportunity to derive valuable insights. Unfortunately, the “way it’s always been done” ideology can present manufacturers with real and sometimes serious consequences.

In December 2018, the FDA posted its final guidance on Data Integrity and Compliance with a Drug cGMP Question & Answer. It specified that all CDMO partners should be able to demonstrate compliance with up-to-date regulations relevant to the project at hand. In the eyes of regulators, rigorous process management and data integrity is taken very seriously. Disruption, slowdowns, and even total shutdowns – such as the FDA’s publication of Form 483 against generics firm Able Laboratories, which later closed¹ – provide several compelling reasons to disrupt tradition, strive for progress, and make the leap towards digital transformation.

From a more proactive (and optimistic) point of view, embracing innovation in biopharmaceutical digital integration and data analytics affords us a very real opportunity to improve our manufacturing processes and quality of our decision making, especially as we navigate a radically and rapidly changing landscape.